The present invention relates to the decontamination art. It finds particular application in conjunction with sterilizing instruments and equipment which contain or potentially contain biological contaminants, such as medical, dental, veterinary, and mortuary instruments and equipment and will be described with particular reference thereto. It is to be appreciated, however, that the invention is also applicable to a wide variety of technologies in which contamination removing or other treating reagents in liquid, gas, or vapor form are blocked by surfaces, connectors, or other treating agent impermeable structures from reaching adjacent surfaces.
Decontamination connotes the elimination, killing, or removal of hazardous or unwanted materials, such as bacteria, mold spores, other pathogenic life forms, radioactive dust, and the like. Disinfection connotes the absence of pathogenic life forms. Sterilization connotes the absence of all detectable life forms, whether pathogenic or not. Thus, a sterilized instrument is also disinfected.
Heretofore, medical, dental, and surgical equipment and instruments have often been sterilized in a steam autoclave. Autoclaves kill life forms with a combination of high temperature and pressure. However, steam autoclaves have several drawbacks. The high temperature pressure vessels tend to be bulky and heavy. The high temperature and pressure tends to curtail the useful life of the endoscopes, rubber and plastic devices, lenses, bearings, portions of devices made of polymeric materials, and the like. Moreover, the autoclave sterilizing and cool down cycle is sufficiently long, that multiple sets of the medical, dental, or surgical instruments are commonly required.
Instruments which cannot withstand the pressure or temperature of the oven autoclave are often sterilized with ethylene oxide gas, particularly in larger medical facilities or hospitals. However, the ethylene oxide sterilization technique also has several drawbacks. First, the ethylene oxide sterilization cycle is even longer than the steam autoclave cycle. Another drawback is that ethylene oxide sterilization is sufficiently sophisticated that trained technicians are commonly required, making it unsuitable for physician and dental offices and for most smaller medical facilities. Yet another drawback is that some medical, surgical, and dental equipment can not be sterilized with ethylene oxide gas.
Anti-microbial fluid disinfection systems have also been utilized for equipment which could not withstand the high temperatures of steam sterilization or long cycle times of ethylene oxide. Commonly, a technician mixes a liquid disinfectant composition and manually immerses the items to be decontaminated. The high degree of manual labor introduces numerous uncontrolled and unreported variables into the disinfection process. There are quality assurance problems with the weakening of the disinfectants due to aging on the shelf, technician error in the mixing of disinfectants, technician error in the control of the immersion times, technician error between immersion and the rinsing of residue, technician error in the rinsing of the residue, exposure to the ambient atmosphere or other not yet disinfected instruments after the rinsing step, and the like.
Some medical items, such as endoscopes, have elongated tubular portions and internal bores. To assure that the internal passages are sterilized, the sterilant is normally pumped through a flexible connector or hose which has an elastomeric fitting on the end. The elastomeric fitting is commonly compression fit into an access port in the bore or stretched over an associated fitting. The elastomeric connector is manufactured of a material with sufficient resiliency that it is frictionally held securely in or around the fitting securely and does not disconnect under the pressure of the pumped sterilant fluid, whether liquid or gaseous.
In some instruments, particularly some type of endoscopes, there are branches in the bores. The branches have different diameters and access to the incoming sterilant. In some instruments, some of the branches tend to receive little or none of the pumped sterilant fluid. To redistribute the sterilant through these sterilant starved bores, plugs or caps close the bores which receive too high a percentage of the sterilant flow. To allow limited flow through the plugged bore, in some cases the plug, cap, or restrictor has a small diameter hole to allow limited sterilant flow. The plugs or caps are again constructed of a resilient polymeric material which are frictionally anchored by their elasticity into the bore or around an associated fitting.
In some applications, the connector at the end of the hose is configured of a non-elastomeric material, such as metal or hard plastic and threaded or otherwise fitted with the same connectors as the item whose internal passages are to be sterilized. This enabled the hose to be threadedly or otherwise securely connected with the item to be sterilized.
Liquid and gaseous anti-microbial systems can kill microbes on all surfaces that the anti-microbial fluid, liquid, or gas can reach. When a connector engages a contaminated surface, there is a potential for a portion of the surface to be shielded from the anti-microbial fluid, liquid, or gas. As the potential for contaminates to avoid contact by the anti-microbial fluid increases, the potential for microbes to survive the decontamination process increases.
The present invention provides a new and improved method and apparatus which eliminates the potential for the pockets of non-fluid contact.